Phase 1 Sjogren's Syndrome Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 5 years old or older.
• You have been diagnosed with a treatment-resistant (refractory) B-cell-related childhood rheumatic disease, which may include juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, or primary Sjögren's syndrome, and you meet specific disease criteria for one of these conditions (confirm with trial site for exact requirements).
• For juvenile dermatomyositis: your condition has not responded to steroids and at least 2 other immune-suppressing medications over at least 6 months, or your disease is rapidly getting worse, or you have complications such as lung, heart, or gut involvement, skin sores, calcium deposits in tissues, or ongoing muscle weakness meeting set measurement thresholds.
• For polyarticular juvenile idiopathic arthritis: after at least 6 months of standard treatment, you still have at least 2 swollen or painful joints with limited movement.
• For systemic sclerosis: your condition has not responded significantly to steroids and other immune-suppressing treatments for more than 3 months, and your skin involvement score is 15 or more out of 51.
• For primary Sjögren's syndrome: your condition has not responded to steroids and at least 2 immune-suppressing medications over at least 6 months, or it is rapidly worsening or affecting organs, and you test positive for a specific antibody (anti-SSA/Ro), and your disease activity score meets a set threshold.
• A blood test shows that your B cells (a type of immune cell) carry a marker called CD19, with more than 5 B cells per microlitre of blood.
• You have either never had CAR-T cell therapy before, or you have had it previously but your disease came back or did not respond well enough.
• Your heart, kidneys, liver, and lungs are functioning at acceptable levels as measured by standard tests (confirm with trial site for exact values).
• You are able to undergo the blood collection process needed to make the CAR-T cells, with no medical reasons preventing this.
• If you are of childbearing age, you have a negative urine pregnancy test and agree to use effective contraception during the trial and for 1 year after treatment.
• You (or your parent or guardian) understand the trial, agree to take part, and have signed a consent form.

Who may not be able to join:

• You have severe organ complications related to your rheumatic disease, such as severely high blood pressure in the lungs (confirm with trial site).
• You have a primary immune deficiency or a severe uncorrected secondary immune deficiency.
• You have a serious, active, or uncontrolled infection, including active or latent tuberculosis or active viral hepatitis.
• There is evidence of an active cancer or a current cancer diagnosis, including blood cancers or solid tumours (except certain fully treated skin cancers).
• You have a significant heart condition, such as a congenital heart defect, serious irregular heart rhythms, large amounts of fluid around the heart, serious heart muscle inflammation, or you need medication to keep your blood pressure stable.
• You have another condition that requires long-term use of steroids or immune-suppressing medications.
• You have had an organ transplant or stem cell transplant within the 3 months before the screening visit, or you have had a significant transplant rejection reaction (graft-versus-host disease grade 2 or above) within the 2 weeks before screening.
• You have active hepatitis B, hepatitis C, HIV, or syphilis based on specific blood test results.
• You have received a live vaccine within 4 weeks before the screening visit.
• You have a positive blood pregnancy test.
• The trial doctors consider there to be any other reason it would not be appropriate for you to participate (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.